The invention relates to a process for introducing a particulate material, for example pellets, granules or powder into a liquid.
In the development and in particular in the routine quality control of solid drug forms, the determination of the active substance dissolution rate in the dissolution process of a drug is of great importance. For this reason, the national pharmacopeias and the European Pharmacopoeia contain exact specifications regarding the instrument parameters of the tester as well as regarding the test procedure. Of primary importance in this regard is the United States Pharmacopeia (USP). Every dissolution tester must comply with the USP specifications. Regular inspections by the health authorities, such as, for example, the Food and Drug Administration (FDA) of the USA, stringently check for compliance with the specifications.
According to the USP specifications, the determination of the active substance dissolution is performed simultaneously with six test specimens, which are introduced in each case into a test vessel containing simulated gastric or intestinal fluid. The dissolution process takes place, for example, at 37 degrees Celsius, the dissolution medium being stirred by means of a standardized stirrer at a specified speed. In many cases, these tests are carried out with tablets or capsules.